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Research
and development

Pharmaceutical and biotechnology companies, doctors and academics research new medicines.

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Research
and development

Pharmaceutical and biotechnology companies, doctors and academics research new medicines.

Who does initial research on medicines?

Tens of thousands of substances are investigated every year by pharmaceutical and biotechnology companies, as well as doctors and academics, for their potential to treat diseases. Only a small number will ever be promising enough to be tested in patients and just a fraction of these will ever have study results good enough to reach the market.

DID YOU KNOW?

Developers of innovative treatments can discuss the scientific, legal and regulatory aspects of their medicine with EMA early in the development through the Innovation Task force.

In 2018, 9 of 22 such requests for early discussions came from university-based or academic groups.

Read more about how potential new medicines are tested

Can EMA influence which medicines should be developed?

EMA cannot compel companies to research particular medicines for a particular condition. However, EMA does publicise areas where there is a need for new medicines to encourage interested parties to research them.

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Evaluation

Developers apply for marketing authorisation and submit data.

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Evaluation

Developers apply for marketing authorisation and submit data.

TABLE OF CONTENTS

What happens before a medicine assessment starts?

A few months before the assessment starts, EMA provides guidance to medicine developers to ensure that their applications for marketing authorisation comply with legal and regulatory requirements to avoid unnecessary delays.

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Who bears the cost of medicine evaluation?

European legislation requires that pharmaceutical companies contribute to the costs of regulation of medicines. As the companies will earn revenues from the sales of medicines, it is fair that they should bear most of the financial costs of regulating them. This means that EU taxpayers do not have to support all the costs of ensuring the safety and effectiveness of medicines.

Companies pay an administrative fee upfront before EMA assessment starts. The administrative fee applicable for each procedure is defined by EU legislation.

What information needs to be submitted in a marketing authorisation application

The data submitted by medicine developers in their application for marketing authorisation must comply with EU legislation. They must include a range of information, including on the way the medicine is manufactured, its effects in laboratory studies, benefits and side effects observed in patients, and how risks will be managed, as well as the proposed information to be provided to patients and doctors.

Read more about information that needs to be submitted in an application Read more about where the data come from

EMA starts its assessment and prepares questions for the medicine developer.

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Evaluation

EMA starts its assessment and prepares questions for the medicine developer.

TABLE OF CONTENTS

What is the key principle underpinning a medicine’s assessment?

The balance between the benefits and risks of a medicine is the key principle guiding a medicine’s assessment. A medicine can only be authorised if its benefits outweigh the risks.

All medicines have benefits as well as risks. When assessing the evidence gathered on a medicine, EMA determines whether the benefits of the medicine outweigh its risks in the group of patients for whom the medicine is intended.

As for all marketing authorisations, it must still be demonstrated that the benefits of the medicine outweigh the risks.

In addition, since not everything is known about a medicine’s safety at the time of its initial authorisation, the way risks will be minimised, managed and monitored once the medicine is more widely used is also an integral part of the assessment and is agreed at the time of authorisation.

While the authorisation of a medicine is based on an overall positive balance between the benefits and risks at population level, each patient is different and before a medicine is used, doctors and their patient should judge whether this is the right treatment option for them based on the information available on the medicine and on the patient’s specific situation.

DID YOU KNOW?

In some cases, for example when a medicine is intended to treat a life-threatening disease for which there is no satisfactory treatment or if the disease targeted is very rare, EMA can recommend marketing authorisation on the basis of less complete or limited evidence on the medicine, provided that further data are provided at a later stage. As for all marketing authorisations, it must still be demonstrated that the benefits of the medicine outweigh the risks.

Who is involved in the assessment of marketing authorisation applications?

A committee of experts (the CHMP) evaluates the applications. Each of its members is supported by a team of assessors.

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How does the CHMP work?

Peer review and collegial decisions are at the heart of the CHMP assessments.

For each application for a new medicine, two committee members − known as rapporteur and co-rapporteur − from different countries are appointed to lead the assessment (for generics only one rapporteur is appointed). They are appointed according to objective criteria to make best use of the available expertise in the EU.

The role of the rapporteur and co-rapporteur is to conduct the scientific evaluation of the medicine independently from each other. They each form an assessment team with assessors from their national agency and sometimes from other national agencies.

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Can the CHMP request more information during the evaluation?

During the evaluation, the CHMP raises questions on the evidence provided in the application and asks the applicant to provide clarifications or additional analyses to address these questions. Responses have to be provided within an agreed timeframe.

The CHMP can raise objections or concerns which can relate to any aspect of the medicine. If unresolved, major objections preclude marketing authorisation.

Major objections can relate for example to the way the medicine was studied, the way it is manufactured, or to the effects seen in patients such as the magnitude of the benefits or the seriousness of the side effects.

EMA often consults additional experts, healthcare professionals and patients.

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Evaluation

EMA often consults additional experts, healthcare professionals and patients.

TABLE OF CONTENTS

What additional expertise can the CHMP rely on?

Experts with specialised scientific knowledge or clinical experience are often consulted during the evaluation to enrich the scientific discussion.

DID YOU KNOW?

External experts are consulted in about a quarter of the assessments of new medicines (excluding generics).

DID YOU KNOW?

EMA regularly exchanges views on ongoing medicines’ assessments with other regulatory agencies such as the US FDA, Health Canada and the Japanese regulatory authorities. These discussions can relate for example to clinical and statistical issues, strategies to manage the risks and studies to be conducted after authorisation.

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How are patients and healthcare professionals involved?

Patients and healthcare professionals understand the issues ‘from the inside’. They are therefore consulted as experts, and provide views on whether the medicine can address their needs.

DID YOU KNOW?

In 2018, patients and healthcare professionals were involved in the assessment of about one in four new medicines (excluding generics).

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What are the measures to safeguard experts’ independence?

Independence is safeguarded by a high level of transparency and the application of restrictions if certain interests are considered to potentially impact impartiality.

EMA policies on handling competing interests have been put in place to restrict the involvement of members, experts and staff with possible competing interests in the Agency’s work while maintaining EMA’s ability to access the best available expertise.

DID YOU KNOW?

The declarations of interests of all the experts, including patients and healthcare professionals, who take part in EMA activities are published on the EMA website. EMA also publishes annual reports on its independence which include facts and figures on declared interests and resulting restrictions.

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EMA recommends whether or not the medicine can be authorised for use in patients.

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Evaluation

EMA recommends whether or not the medicine can be authorised for use in patients.

How does the CHMP make its final recommendation?

The final CHMP recommendation is reached by a formal vote. Ideally, the CHMP will come to a consensus and unanimously recommend either the approval or refusal of the marketing authorisation; such a consensus is reached in 90% of cases. However, when a final recommendation by consensus cannot be reached, the committee’s final recommendation will represent the majority view.

What information is publicly available during the evaluation of a new medicine and once a decision has been made?

EMA provides a high level of transparency about its medicine assessment by publishing meeting agendas and minutes, reports describing how the medicine was assessed and the clinical study results submitted by medicine developers in their applications.

DID YOU KNOW?

As of October 2018, EMA had published the clinical study results submitted by medicine developers in their applications for over 100 medicines recently assessed by EMA. These are available for public scrutiny on EMA’s dedicated website on clinical data.

Read more
Calendar
of a medicine’s
evaluation

Authorisation

The European Commission takes a final decision on whether the medicine can be marketed in the EU

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Authorisation

The European Commission takes a final decision on whether the medicine can be marketed in the EU

Who grants EU-wide marketing authorisation?

EMA is a scientific body with the expertise required to assess the benefits and risks of medicines. However, under EU law it has no authority to actually permit marketing in the different EU countries. The role of EMA is to make a recommendation to the European Commission which then takes a final legally binding decision on whether the medicine can be marketed in the EU. This decision is issued within 67 days of receipt of EMA’s recommendation. The Commission is thus the authorising body for all centrally-authorised products.

Commission decisions are published in the Union Register of medicinal products for human use.

DID YOU KNOW?

While the majority of new, innovative medicines are evaluated by EMA and authorised by the European Commission in order to be marketed in the EU, most generic medicines and medicines available without a prescription are assessed and authorised at national level in the EU. In addition, many older medicines available today were authorised at national level because they were marketed before EMA was created. Most Member States have registers of nationally authorised medicines.

Access

National and regional authorities decide on pricing and reimbursement.

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Access

National and regional authorities decide on pricing and reimbursement.

Who makes decisions on patient access to medicines?

Once a medicine has received an EU-wide marketing authorisation, decisions about pricing and reimbursement take place at national and regional level. As those choices must be made in the context of the national health system of each country, EMA has no role in decisions on pricing and reimbursement. However, the Agency collaborates with national bodies, such as HTA bodies, to facilitate these processes.

DID YOU KNOW?

In 2018 simultaneous advice from EMA and HTA bodies was provided upon request during the development of 27 medicines. Patients were involved in two thirds of these cases.

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Safety monitoring

Once the medicine is authorised, EMA and national authorities continuously monitor its safety.

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Safety monitoring

Once the medicine is authorised, EMA and national authorities continuously monitor its safety.

How is the safety of a medicine ensured once it has been put on the market?

Once a medicine has been authorised for use in the EU, EMA and the EU Member States continuously monitor its safety and take action if new information indicates that the medicine is no longer as safe and effective as previously thought.

See the range of activities that EMA carries out to monitor the safety of medicines.

Scientific advice

EMA can provide scientific advice to help medicine developers generate robust data on medicines.

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Scientific advice

EMA can provide scientific advice to help medicine developers generate robust data on medicines.

TABLE OF CONTENTS

What is scientific advice?

For a medicine to be authorised, medicine developers have to demonstrate that it is effective, safe and of good quality.

During a medicine’s development, a developer can request guidance and direction from EMA on the best methods and study designs to generate robust information on how well a medicine works and how safe it is. This is known as scientific advice.

Then, when applying for a marketing authorisation, the developer submits all the data generated on the medicine to EMA. The Agency assesses this information and determines whether or not the medicine is safe and beneficial to patients.

DID YOU KNOW?

Scientific advice:

  • is not a pre-assessment of the benefits and risks of a medicine
  • does not guarantee that a medicine will receive a marketing authorisation
DID YOU KNOW?

Two out of three development programmes submitted for scientific advice were considered not suitable for a future assessment of the medicine’s benefits and risks, according to an analysis done in 2015. Following scientific advice, 63% of these trials were modified to include a better way to assess the medicine’s effectiveness or a more appropriate comparator.

Read more about why EMA provides scientific advice

Why are medicine regulators the ones giving scientific advice?

Medicine regulators have a unique knowledge and experience of how medicines should be developed gained from years of assessment of medicines. It is their duty to share this knowledge and promote a more effective medicine development for the benefit of patients.

Does EMA provide advice in any other ways?

Yes. EMA develops scientific guidelines to advise medicines developers on the best way to study their medicines; however these obviously have to address general situations and will not cover non-standard, innovative approaches as they are developed. Scientific advice therefore complements and builds on existing guidelines but is tailored to the specific case, and can eventually be used to update or develop new guidelines.

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Developers ask specific questions about their plans to develop their medicine.

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Scientific advice

Developers ask specific questions about their plans to develop their medicine.

How is scientific advice paid for?

Applicants pay an administrative fee for scientific advice. The provision of scientific advice by EMA is required by the EU legislation, which also defines the administrative fees to be charged to the applicant.

Reductions apply for certain types of medicines and applicants: there is a 75% fee reduction for medicines for rare diseases, known as orphan medicines; micro, small and medium sized companies (SMEs) have a 90% fee reduction.

DID YOU KNOW?

In 2018, about a third of the 634 scientific advice finalised were provided to SMEs and a quarter related to orphan medicines. Thanks to fee reductions SMEs, who are the originators of a great number of innovative medicines, can access scientific advice during the development of their medicines.

What happens during scientific advice?

During scientific advice, experts respond to specific scientific questions related to the development of a particular medicine.

The developer of a medicine presents the way it plans to develop its medicine and identifies questions and possible solutions. EMA then gives advice on the developer’s proposals. During scientific advice EMA does not evaluate the results of the studies and in no way concludes on whether the benefits of the medicine outweigh the risks.

Read more about the kind of questions addressed during scientific advice

EMA responds to the questions, often consulting additional experts and patients.

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Scientific advice

EMA responds to the questions, often consulting additional experts and patients.

TABLE OF CONTENTS

Who’s involved in scientific advice?

Dozens of experts from a range of disciplines are involved in responding to the questions asked.

At EMA, the Committee for Medicinal Products for Human Use (CHMP) is responsible for assessing marketing authorisation applications. One of its roles is also to support research and development by providing scientific advice. This task is passed by the CHMP to EMA’s Scientific Advice Working Party (SAWP). The answers to the questions asked by the developer are elaborated by the SAWP, and then the final advice is formally adopted and issued by the CHMP.

Read more about the SAWP

Are patients involved in scientific advice?

Patients are often involved in scientific advice. They are invited to share their real-life perspective and experience in relation to a particular medicine in their disease area. This can help medicine developers and regulators understand better what will work for that patient group and what they consider important.

Additional external experts may also be consulted, further widening the pool of expertise the SAWP can call on.

DID YOU KNOW?

In 2018, one in five scientific advice procedures involved patients, and the SAWP members considered that in almost every case (around 90%) patients provided added value to the scientific advice. In about one in four cases, the scientific advice recommended that the development plan be modified to reflect patient advice.

What are the measures to safeguard experts’ independence during scientific advice?

EMA checks every expert’s declaration of interests prior to their involvement in scientific advice and restrictions are applied if any interests are considered to potentially impact impartiality.

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EMA provides its advice, which is not binding either on EMA regarding future assessment of the medicine or on the developer, which can decide not to follow it.

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Scientific advice

EMA provides its advice, which is not binding either on EMA regarding future assessment of the medicine or on the developer, which can decide not to follow it.

Does giving scientific advice influence EMA’s assessment of the medicine?

Scientific advice and the assessment of the benefits and risks of a medicine are different by nature: while scientific advice looks at how a medicine should be studied to generate robust evidence, the assessment at the time of marketing authorisation looks at the actual evidence from the studies, to determine whether the medicine’s benefits outweigh its risks, regardless of any advice previously given.

DID YOU KNOW?

Complying with scientific advice increases the chances of receiving marketing authorisation but it does not guarantee it. An analysis done in 2015 showed that 15% of companies who complied with scientific advice provided by EMA received a negative opinion at the time of applying for marketing authorisation. This compares with 25% overall.

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What does EMA publish on the outcomes of scientific advice?

During the development and assessment phases, the detailed advice given to a company is not made public. This is because disclosing information at this stage may undermine research and development efforts and so discourage research in new medicines.

However, information is made available as soon as a medicine obtains marketing authorisation.

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Scientific
advice – details
of the process

Scientific advice – details of the process

Two experts, supported by independent teams, conduct separate assessments; additional experts and stakeholders are often consulted.
A medicine developer who wishes to request scientific advice first needs to notify EMA and send a briefing document. A meeting can be organised, in particular for first users of scientific advice or for complex medicines.
The developer then sends a list of specific scientific questions and proposed responses. EMA determines whether the questions are valid or not for scientific advice.
For each scientific advice procedure (or ‘protocol assistance’ procedure for orphan medicines) validated, two members of the SAWP who have sound expertise to address the scientific questions are appointed as coordinators.
Each coordinator forms an assessment team calling on assessors from their national agency or other EU agencies. Each team prepares a report addressing the scientific questions; they draft a list of issues for discussion with all the other members of the SAWP and may ask the applicant for any additional documents or clarifications.
If the SAWP wishes to address specific issues with the medicine developer, it will organise a meeting, particularly where it disagrees with the proposed plan and proposes alternative development plans.
The SAWP consults relevant EMA committees (for example EMA’s Committee for Advanced Therapies (CAT) or EMA’s Committee for Orphan Medicines (COMP)) and scientific working parties. Additional external experts may also be consulted, further widening the pool of expertise the SAWP can call on.
Patients are also often consulted. If EMA decides to respond to the medicine developer in writing, patients are asked to provide comments; if EMA decides to meet with the medicine developer, patients are invited to attend.
The SAWP consolidates a response to the scientific questions. Final advice is discussed and adopted by the CHMP and then sent to the medicine developer.

This interactive tool covers medicines for human use that are authorised via EMA through the EU centralised procedure. It does not cover medicines authorised through national procedures (including the decentralised procedure and the mutual recognition procedure), by national medicines authorities in the EU Member States.

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